Hodgkin s disease MedDRA version: 9.1 Level: HLT Classification code 10020243 Term: Hodgkin's disease NEC
Conditions
Interventions
Trade Name: VELBE EV 1FL 10MG
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Vinblastine
CAS Number: 143-67-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Hystologically proven diagnosis of Hodgkin disease, according to WHO classification 2.Stage IA, IB, IIA, IIB with one of the following risk factors bulky disease defined as a mediastinal mass 8805; 1/3 maximum transverse thorax diameter or any lesion 8805; 5 cm extranodal involvement ESR 8805; 50 A ; 8805; 30 B 3 or more lymph node regions involved 3.Stage III, IV 4.Performance status ECOG 61603; 2 5.Written informed consent 6.Age 61619;18 yrs and 61603; 65 yrs Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Previous chemotherapy and or radiotherapy for Hodgkin disease 2.Any other malignancy or history of prior malignancy except non-melanoma skin tumours or in situ cervical carcinoma 3.Chronic disease uncontrolled by therapy 4.HIV positivity 5.Abnormal blood count ANC 1.5 x 109/L, platelet count 150 x 109/L, Hob 9 g/dl due to other causes than Hodgkin disease 6.Abnormal renal function serum creatinine 2.5 x ULN due to other causes than Hodgkin disease 7.Abnormal liver function total bilirubin 1.5 x ULN, transaminase 2.5 x ULN due to other causes than Hodgkin disease 8.Pregnancy and/or lactation 9.Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study 10.Patients unwilling or unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: primary endpoint of this study is to reach a progression free survival PFS at three years greater than 80 ;Secondary Objective: - Overall survival time from start of treatment to death for any cause at three years - Haematological and non haematological toxicity; - Need for transfusions support - Time to recycle - Incidence of severe infectious event - Late toxicity;Primary end point(s): progression free survival PFS at three years | — |
Countries
Italy
Outcome results
None listed